8,8-dioctyl-1,4-dioxa-7,9-dithia-8-stannacycloundecane-5,11-dione

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.02 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

50

Dose descriptor starting point:

NOAEL

Value:

0.5 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

0.88 mg/m³

Explanation for the modification of the dose descriptor starting point:

Oral NOAEL_rat× (1/0.38 m³/kg bw) × (6.7 m³/10m³) × (100% /100%) = 0.5 × 2.63 × 0.67 × 1

AF for dose response relationship:

1

Justification:

The starting point is a clear NOAEL

AF for differences in duration of exposure:

2

Justification:

subchronic to chronic

AF for interspecies differences (allometric scaling):

1

Justification:

Not applicable for inhalation

AF for other interspecies differences:

1

Justification:

Addressed by modification of starting point

AF for intraspecies differences:

5

Justification:

Default value for workers

AF for the quality of the whole database:

2

Justification:

Read-across from a structurally related substance

AF for remaining uncertainties:

2.5

Justification:

Default value for remaining uncertainties

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.05 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

DNEL extrapolated from long term DNEL

Explanation for the modification of the dose descriptor starting point:

3x the long-term DNEL = 0.018 × 3 =0.05 mg/m³

Local effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.25 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

200

Dose descriptor starting point:

NOAEL

Value:

0.5 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

50 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Oral NOAEL_rat× (100% / 1%) = 0.5 × 100

AF for dose response relationship:

1

Justification:

The starting point is a NOAEL

AF for differences in duration of exposure:

2

Justification:

Subchronic to chronic

AF for interspecies differences (allometric scaling):

4

Justification:

Default - Rat to human

AF for other interspecies differences:

1

Justification:

Addressed by modification of starting point

AF for intraspecies differences:

5

Justification:

Default value for workers

AF for the quality of the whole database:

2

Justification:

Read-across from a structurally related substance

AF for remaining uncertainties:

2.5

Justification:

Default value for remaining uncertainties

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.75 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

DNEL extrapolated from long term DNEL

Explanation for the modification of the dose descriptor starting point:

3 x the long-term DNEL = 0.25 × 3 =0.75 mg/kg bw/day

Local effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified

Additional information - workers

In a subchronic (13-week) repeated dose oral toxicity study in rats (1970) using a mixture of DOTE, MOTE:and TOTE (97: 0.3: 2.7) (CAS 15571 -58 -1, CAS 27107-89-7 and CAS 61912-55-8) the NOAEL was determined to be 10 ppm (equivalent to 0.5 mg/kg bw/day). The study predates GLP, but is well documented and quality assurance is comparable. The study was on a structurally related substance DOTE (as well as MOTE and TOTE at much lower concentration) the NOAEL was 10 ppm (equivalent to 0.5 mg/kg bw/day) based on effects on thymus weight.

DOT-EGMA did not show any local effect and is neither a skin irritant nor has any skin sensitising potential, based on the read-across substance DOTE.

DOT-EGMA was tested in an in vitro eye irritation, which concluded that no prediction of eye irritation can be made. In vivo test data from the read across substance, DOTE (CAS 15571-58-1), concluded that the substance is not irritating to the eye.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population

No DNELs have been derived for general population as exposure does not occur during the lifecycle of the substance.

 

The substance is not used by consumers or professionals and only has manufacture, formulation and industrial uses.

 

The substance is used in the industrial processing of polymers, where it is added as a stabilizer and also as a catalyst/process regulator in the production of polyurethanes or silicones. During the processing of the polymer the substance will be completely used up and as a reactive catalyst the substance is destroyed in the production of polyurethanes or silicones. As such the substance does not exist in the products, therefore in-direct exposure of the general population via releases from the end products are not possible. Indirect exposure of the general population via releases to the environment is also not considered to occur, as the substance is only used in industrial settings where there will be effective waste management processes to prevent release.